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Director, Regulatory Affairs: Labeling and Commercial-Promotional Review

Novavax
Gaithersburg, MD 20877
Full-time, Part-time
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Job Description

Job Description

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc.(Nasdaq: NVAX) is a late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

We are seeking a highly motivated and experienced individual for a Director position to lead and build a global labeling group within our Regulatory Affairs organization. This position is located at our Gaithersburg, MD facility and will report to the Vice President of Regulatory Affairs. This position will develop, manage, and execute global labeling strategy working in close collaboration with cross-functional teams across the organization.

Responsibilities include but are not limited to:

The Director of Labeling and Commercial Promotional Review has the following responsibilities:

  • Overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the development and maintenance of the Core Data Sheets (CDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU, other global labeling as appropriate (eg, UK, Canada, Australia, etc), and their associated Patient Labeling Documents.
  • Ensure commercial and promotional materials are consistent with guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
  • Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, CSI, USPI, SPC, other global labeling, and their associated Patient Labeling Documents. Engage in and contribute to Labeling Team discussions regarding these documents.
  • Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures.
  • Prioritize Labeling activities and set clear targets using project management tools to ensure internal and external deadlines are met. Identify and assist teams to overcome barriers in achieving quality and compliance.
  • Communicate label update plans in a timely manner.
  • Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
  • Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic areas.
  • Provide strategic advice for the development of submissions to be sent to the Office Of Prescription Drug Promotion or Advertising and Promotion Labeling Branch.
  • Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances.
  • Lead training for Commercial teams on 2253 regulations and FDA regulations on advertising and promotion.
  • Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.

Minimum requirements:

  • Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as Pharm.D., Ph.D. are an advantage but not essential.
  • A minimum of 12 years in the drug development industry with at least 10 years in Regulatory Affairs with focus on labeling expertise.
  • Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS), Core Safety Information (CSI); experiences of review and implications of the CDS/CSI an advantage.
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
  • Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
  • Proven aptitude to analyze and interpret efficacy and safety data.
  • Experience communicating and negotiating with APLB or OPDP.
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
  • Excellent written and verbal communication skills essential.
  • Demonstrated project management skills and attention to detail required.
  • Proven ability to negotiate, influence and problem solve across a highly matrixed team.

Key Skills and Competencies:

  • Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
  • Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents and the dynamics of Labeling Team purpose and objectives.
  • Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
  • Able and willing to work in a fast-paced environment while handling multiple priorities.
  • Shows strong initiative and drive. Must be an organized self-starter.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.



Job Posted by ApplicantPro
Posting ID: 606650681Posted: 2021-02-25